Evaluation of ultrasonic axillary dissection in preservation of intercostobrachial nerve function and lymphatic sealing in management of axilla in patients with breast cancer: a randomized controlled trial

Phase 3

Completed

• Conditions: This study includes 40 patients presented with early breast cancer (T1 and T2) under- went BCS or MRM. The patients randomly assigned into 2 groups, group A: subjected to ANLD using Harmonic Focus too; Harmonic, electrocautery, drain volume, axillary numbness

• Registration Number: TCTR20200903004
• Lead Sponsor: Faculty of medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-09-30
• Study Start: 2020-09-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Inclusion criteria
Female patients with early (T1 or T2) cancer breast fit for both BCS and MRM.

Exclusion Criteria

(1) Patients with carcinoma in-situ.
(2) locally advanced breast carcinoma (T3 and T4).
(3) Metastatic carcinoma.
(4) Recurrent breast carcinoma.
(5) Patients who receive neoadjuvant chemotherapy.
(6) Breast sarcomas.
(7) Benign breast lump.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
operation time and blood loss postoperative hospital stay, total drainage volume, mean drain durati 2.8 years time from skin to skin, blood loss by sponge count and weight and suction volume

Secondary Outcome Measures

Name	Time	Method
Preservation of axillary sensation 2.8 years using a piece of ice and compare the sensation with the other axilla (superficial sensation).